The Clinical Evaluation Plan (CEP) is the document that defines the clinical evaluation strategy for a given device. Annex XIV, Part A of the MDR sets out its required content. It is the first document notified bodies ask for when they review a clinical file — even before the CER.
A CEP that fails to identify the device’s clinical gaps and does not define how they will be addressed is a merely formal document. Notified bodies spot it immediately.
The content required by Annex XIV, Part A, Section 1(a)
The clinical evaluation plan includes at least the following elements.
The relevant general safety and performance requirements. Identification of the Annex I requirements whose demonstration requires relevant clinical data.
The intended purpose of the device. Specification of the intended purpose.
The intended target groups. Clear specification of the intended target groups, with clear indications and contra-indications.
The intended clinical benefits. Detailed description of the intended clinical benefits to patients, with relevant and specified clinical outcome parameters.
The methods for examining clinical safety. Specification of the methods used to examine the qualitative and quantitative aspects of clinical safety, with clear reference to the determination of residual risks and side-effects.
The benefit-risk acceptability criteria. An indicative list and specification of the parameters used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and intended purposes of the device.
Specific components. An indication of how benefit-risk issues relating to specific components, such as the use of pharmaceutical substances or non-viable animal or human tissues, are to be addressed.
The clinical development plan. The progression from exploratory investigations (first-in-man, feasibility and pilot studies) to confirmatory investigations (pivotal studies) and a PMCF, with milestones and a description of potential acceptance criteria.
The PMCF plan (Annex XIV, Part B) and the update frequency of the clinical evaluation report (Article 61(11)) are not part of this list: they are related documents that the CEP must keep consistent. Likewise, methodological references (MDCG guidance, ISO 14155 for clinical investigations) help structure the plan but are not a required heading; MEDDEV 2.7/1 rev. 4 belongs to the Directives regime.
What distinguishes a robust CEP from a merely formal one
A robust CEP identifies the device’s clinical gaps from the outset. It answers the question: “What do I not yet know about the safety and clinical performance of this device under real-world conditions of use?” These gaps are not an admission of weakness — they are unavoidable for any device that does not yet have a long clinical history. Notified bodies expect them to be identified honestly.
The correspondence between the gaps in the CEP and the content of the PMCF plan is the first consistency check notified bodies carry out. If the CEP identifies a lack of data on patients over 75, the PMCF must provide for specific data collection on this sub-population. If the link is missing, the reviewer raises it.
The most common mistake
Writing the CEP after the CER, in order to justify after the fact what has already been done. The CEP is meant to precede the CER and define its method. A CEP drafted after the event is often inconsistent with the CER, and notified bodies that read the two in order detect this without difficulty.